FDA Releases Final Guidance on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act

Summary

The Food and Drug Administration (FDA) has released a final guidance for industry on citizen petitions and petitions for stay of action subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, outlining the agency's current thinking on petition requirements and considerations for delaying application approval. This guidance finalizes a draft released in October 2018.